FDA · official record K882400Substantially Equivalent

AMORPHUS SILK BY DENTRAX

Name: AMORPHUS SILK BY DENTRAX — FDA K882400
Creator: Dale T. Dupuis
Keywords: AMORPHUS SILK BY DENTRAX, AMORPHUS SILK BY DENTRAX, K882400, EBF, FDA

United StatesEBFDale T. Dupuis

Verified

Official record identity

FDA application number: K882400
Decision date: July 15, 1988
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Dale T. Dupuis

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1988-06-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.